[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Pages 37397-37398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96E-0452]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; VERLUMA<SUP>TM</SUP>

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for VERLUMA<SUP>TM</SUP> and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of an application to the 
Commissioner of Patents and Trademarks, Department of Commerce, for the 
extension of a patent which claims that human biological product.

ADDRESSES: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6620.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 100-670) generally provide 
that a patent may be extended for a period of up to 5 years so long as 
the patented item (human drug product, animal drug product, medical 
device, food additive, or color additive) was subject to regulatory 
review by FDA before the item was marketed. Under these acts, a 
product's regulatory review period forms the basis for determining the 
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A 
testing phase and an approval phase. For human biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human biological product and 
continues until FDA grants permission to market the biological product. 
Although only a portion of a regulatory review period may count toward 
the actual amount of extension that the Commissioner of Patents and 
Trademarks may award (for example, half the testing phase must be 
subtracted as well as any time that may have occurred before the patent 
was issued), FDA's determination of the

[[Page 37398]]

length of a regulatory review period for a human biological product 
will include all of the testing phase and approval phase as specified 
in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human biological product 
VERLUMA<SUP>TM</SUP> (nofetumomab). VERLUMA<SUP>TM</SUP> is indicated 
for the detection of extensive stage disease in patients with biopsy 
confirmed, previously untreated small cell lung cancer. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for VERLUMA<SUP>TM</SUP> (U.S. Patent No. 
4,897,255) from NeoRx Corp., and the Patent and Trademark Office 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated July 9, 1997, FDA advised 
the Patent and Trademark Office that this human biological product had 
undergone a regulatory review period and that the approval of 
VERLUMA<SUP>TM</SUP> represented the first permitted commercial 
marketing or use of the product. Shortly thereafter, the Patent and 
Trademark Office requested that the FDA determine the product's 
regulatory review period.
    FDA has determined that the applicable regulatory review period for 
VERLUMA<SUP>TM</SUP> is 3,360 days. Of this time, 925 days occurred 
during the testing phase of the regulatory review period, 2,435 days 
occurred during the approval phase. These periods of time were derived 
from the following dates:
    1. The date an exemption under section 351 of the Public Health 
Service Act became effective: June 11, 1987. The applicant claims 
September 4, 1987, as the date the investigational new drug application 
(IND) became effective. However, FDA records indicate that the IND 
effective date was June 11, 1987, which was 30 days after FDA receipt 
of the IND.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act: December 21, 1989. FDA has verified the applicant's claim 
that the Product License Application (PLA) for VERLUMA<SUP>TM</SUP> 
(PLA 90-0150) was initially submitted on December 21, 1989.
    3. The date the application was approved:  August 20, 1996. FDA has 
verified the applicant's claim that PLA 90-0150 was approved on August 
20, 1996.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
Patent and Trademark Office applies several statutory limitations in 
its calculations of the actual period for patent extension. In its 
application for patent extension, this applicant seeks 1,298 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before September 8, 1998, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before January 6, 1999, for a determination regarding whether the 
applicant for extension acted with due diligence during the regulatory 
review period. To meet its burden, the petition must contain sufficient 
facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th 
Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format 
specified in 21 CFR 10.30.
    Comments and petitions should be submitted to the Dockets 
Management Branch (address above) in three copies (except that 
individuals may submit single copies) and identified with the docket 
number found in brackets in the heading of this document. Comments and 
petitions may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: June 29, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-18408 Filed 7-9-98; 8:45 am]
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